Rigid and Flexible Monopolar HF Electrodes Instruction Manual

Important general notes and instructions Make sure that this product is used only as intended and described in this instruction manual, by adequately trained and qualified medical personnel, Maintenance and repair must be carried out by authorized experts. Use the product only in the combinations and with the accessories and spare parts specified in this instruction manual. Use other combinations, accessories and replacement parts only if they are expressly intended for the planned appli­ cation and if the performance characteristics and safety requirements are met. The product must not be altered in any way. Reprocess the product in accordance with the manual before every use and before return shipment to protect the pa­ tient, user and third parties. This manual is an integral part of the product and must be stored in such a way that it is accessible at any time during its entire life cycle. This manual must be passed on to any subsequent owner or user. Immediately on receipt, check the product and its accessories for completeness and possible damage. Should the shipment give rise to complaints, please inform the manufacturer or supplier immediately. Subject to technical changes! Due to ongoing developments the illustrations and technical data may deviate slightly.

Safety instructions and levels of danger Symbol

Level of danger

WARNING!

Failure to observe can result in death or serious injury.

CAUTION!

Failure to observe can result in slight injury or damage to the product.

. .

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IMPORTANT!

Failure to observe can result in damage to the product or surroundings.

NOTE!

User tips for optimum device use and other useful information. GERMANY RICHARD WOLF GmbH 75438 Knittlingen Pforzheimerstr. 32 Telephone: +49 70 43 35-0 Telefax: +49 70 43 35-4300 MANUFACTURER [email protected] www.richard-wolf.com

USA RICHARD WOLF Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Toll Free: 001 (800) 323 - 9653 Phone: 001 (847) 913 - 1113 Fax: 001 (847) 913 - 1488 [email protected] www.richardwolfusa.com

UK RICHARD WOLF UK Ltd. Waterside Way Wimbledon SW17 0HB Telephone: + 44 20 89 44 74 47 Telefax: + 44 20 89 44 13 11 [email protected] www.richardwolf.uk.com

BELGIUM / NETHERLANDS N.V. Endoscopie RICHARD WOLF Belgium S.A. Industriezone Drongen Landegemstraat 6 9031 Gent Drongen Telephone: +32 92 80 81 00 Telefax: +32 92 82 92 16 [email protected] www.richard-wolf.be

FRANCE RICHARD WOLF France S.A.R.L. Rue Daniel Berger Z.A.C. La Neuvillette F-51100 Reims Telephone: +33 3 26 87 02 89 Telefax: +33 3 26 87 60 33

AUSTRIA RICHARD WOLF Austria Ges.m.b.H. Wilhelminenstraße 93 a A-1160 Vienna Telephone: +43 14 05 51 51 Telefax: +43 14 05 51 51 45

[email protected]

[email protected] www.richard-wolf.com

Marketing Office U.A.E RICHARD WOLF Middle East P.O. Box 500283 AL Thuraya Tower 1 9th Floor, Room 904, Dubai Telephone: + 9 71 43 68 19 20 Telefax: + 9 71 43 68 61 12 [email protected] www.richard-wolf.com

INDIA RICHARD WOLF India Private Ltd. JMD Pacific Square No. 211 A, Second Floor Behind 32nd Milestone Gurgaon - 122 001 National Capitol Region Telephone: + 91 12 44 31 57 00 Telefax: + 91 12 44 31 57 05 [email protected] www.richard-wolf.com

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Contents 1

Technical description...

1

2

Intended use...

1

3

Indications and field of use...

1

4 4.1 4.2

Contraindications and side effects... Contraindications... Side effects...

1 1 1

5

Combinations...

2

6 6.1 6.2

Illustration... Legend and identification... Symbol...

3 3 3

7 7.1 7.2 7.2.1 7.3

Use... Preparation... Additional notes and instructions for use... Irrigation fluid... HF applications...

4 4 4 4 4

8 8.1 8.2

Checks... Visual check... Function check...

6 6 6

9 9.1

Reprocessing and maintenance... Reprocessing procedure...

7 7

10 10.1

Technical data and order data... 10 Accessories... 11

11 11.1

Operating, storage, transport and shipping conditions... 11 Disposal of product, packaging material and accessories... 11

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I

1

Technical description Z HF electrodes, monopolar, rigid / flexible consist of: ' isulated sheath ' distal metal electrode head electrode head shapes: G Coagulation electrode G Hook electrode G Needle electrode G Loop electrode G Spatula electrode G Mushroom electrode G Myoma dissector ' handle ' HF connector

2

Intended use

HF electrodes, monopolar, rigid / flexible, are used under endoscopic view: ' for tissue / vessel coagulation (hemostasis) ' for cutting by means of high frequency current These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.

3

Indications and field of use

The product is used for therapy in conjunction with endoscopic accessories. This product is used in the following medical disciplines: Z Surgery ' e.g. Laparoscopy Z Urology Z Gynecology Z ENT Z Thoracoscopy Z Orthopedics

.

IMPORTANT! The permissible fields of use / medical disciplines of the individual HF electrodes are listed in section 10 and must be adhered to.

4

Contraindications and side effects

4.1

Contraindications Contraindications directly related to the product are presently unknown. On the basis of the patient's general condition the doctor in charge must decide whether the planned use is possible or not. Comply with the laws and regulations valid in your country. For further notes and instructions please refer to the latest medical literature.

4.2

Side effects

1

No side effects are to be expected if the system is used as intended.

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5

Combinations

HF electrodes, monopolar, rigid / flexible are used in conjunction with: Z HF surgical devices Z HF monopolar connection cables Z Endoscopic accessories, e.g. ' Operating endoscopes ' Fiberscopes ' Trocar sleeves ' Sheaths ' etc.

CAUTION! Do not combine products incorrectly! Injuries of the patient, user or others as well as damage to the product are possible. The different products can only be used together if their intended uses and rele­ vant technical data (such as working length, diameter, peak voltage, etc.) are the same. Follow the instruction manuals of the products used in combination with this product. Follow the "Notes and instructions on HF applications", order no.: GA-S 002 as well as the HF device manufacturer's instructions.

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2

6

Illustration

4 1

2

#

2

#

B

1

2

3

#

A

D

2

4 1

4

1

E

1

2

1

2

#

# 4

G

Fig. 1

2

#

F

6.1

C

1

2

#

#

Legend and identification

6.2

Item

Designation

Item

Designation

A

Coagulation electrode

1

Electrode head

B

Hook electrode

2

Isulation / sheath tube

C

Loop electrode

3

D

Mushroom electrode

4

E

Spatula electrode

F

Myoma dissector

G

Needle electrode

#

HF connector

for 8106.xxx monopolar HF connection cable

HF connector

for 815.xxx monopolar HF connection cable

Product no.

Symbol Symbol

Designation Follow the instruction manual

REF

Order number

LOT

Lot identification Manufacturer Identification in conformity with Medical Product Directive 93/42/EEC, only valid if the product and/or the packaging is marked with this identification. Products of category IIa and above, as well as sterile products or products with measuring function of category I, are additionally marked with the code no. of the notified body (0124).

3

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7

Use CAUTION! The products have only limited strength! Excessive force will cause damage, impair the function and therefore endanger the patient. Immediately before and after each use, check the products for damage, loose parts and completeness. Make sure that no missing parts remain in the patient. Do not use the products if they are damaged or incomplete or have loose parts.

7.1

Preparation

7.2

Additional notes and instructions for use

7.2.1

Irrigation fluid

Z Carry out a check: see sections 8 and 8.1 Z Apply the neutral electrode. Z Connect the HF monopolar connection cable (Richard Wolf Type 8106.xxx / 815.xxx) to the HF connector (3) (4).

CAUTION! Take care not to use the wrong irrigation fluid! Do not use high-conductivity irrigation fluid in monopolar HF applications! • Increased danger of patient leakage currents • No function of the HF instrument The user must choose the irrigation fluid as required by the application. The irri­ gation fluid must have a low electrical conductivity. Do not use saline (NaCl solution). CAUTION! Danger of elevated temperatures when working without irrigation fluid! Injuries to the mucous membrane due to excessive temperatures endanger the patient. Activate the electrode only while it is immersed in irrigation fluid and under con­ tinuous irrigation.

7.3

HF applications

Follow the "Notes and instructions on HF applications", order no. GA-S 002 as well as the HF device manufacturer's instructions.

WARNING! Danger of injury if the HF instrument is not visible through the scope ! Inadvertent tissue damage as well as damage to the distal end of the electrodes and to instrument parts is possible. Use HF instruments only within the scope of their specifications (voltage strength, duty factor). Activate HF instruments only after the part carrying high-frequency current has become fully visible through the scope and contact is made with the area to be treated.

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4

CAUTION! Careful if HF voltage is too high! Danger of injury if the insulation of the HF electrodes is damaged. Exceeding the specified maximum permissible recurring peak voltage in combi­ nation with HF surgical devices and/or selecting the wrong mode can destroy the insulation and result in leakage currents. The patient, user or others can suffer thermal tissue damage. Use HF electrodes in combination with HF surgical devices only up to the maxi­ mum recurring peak voltage (VS ): Diameter of sheath tube:

Mode: Cutting / Coagulation

Spray coagulation

Ø 0.85 mm - Ø 2.9 mm

1000 VS / 2500 VS

3600 VS

Ø 3.0 mm - Ø 4.9 mm

1500 VS / 3000 VS

3600 VS

2000 VS / 3500 VS

3600 VS

≥

Ø 5mm

CAUTION! Thermal tissue injuries due to damaged insulation! On HF instruments that have been frequently reprocessed and on aged HF in­ struments, the insulation can be damaged. A damaged insulation causes leakage currents leading to thermal tissue injuries of the patient, user or others. Check the insulation for damage before use. Do not use HF instruments once the insulation is damaged.

Fig. 2

CAUTION! Danger of HF arcing! Insufficient distance between the parts conducting high-frequency current and other conductive parts can lead to unintentional tissue damage and damage to the instru­ ment. When the HF current is activated, the parts of HF instruments carrying high-fre­ quency current must have a safety distance of at least 10 mm from the distal end of other conductive parts. In the case of HF flashover, replace the electrode immediately, check the instru­ ment for damage and send in for repair if necessary to avoid consequential dam­ age. CAUTION! Careful if HF output power is incorrectly selected! Injuries to the patient as well as damage to the product are possible. The power should be set on the basis of the surgeon's experience and training in view of the corresponding indication.

5

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8

Checks CAUTION! Be careful if products are damaged or incomplete! Injuries of the patient, user and others are possible. Run through the checks before and after each use. Do not use the products if they are damaged, incomplete or have loose parts. Return damaged products together with any loose parts for repair. Do not attempt to do any repairs yourself.

8.1

Visual check

Z Check the products, in particular their distal area, and the accessories for: ' damage ' sharp edges ' loose or missing parts ' rough surfaces. Z Any inscriptions or identification necessary for the safe intended use must be legible. ' To prevent wrong handling or reprocessing, any illegible lettering, labeling or identification must be reinstated. Z Check the insulation. In the case of damaged insulation replace the HF elec­ trode immediately.

Fig. 3

8.2

Function check

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Z Check the HF monopolar connection cable for compatibility with the instrument and the HF surgical device.

6

9

Reprocessing and maintenance WARNING! Creutzfeldt-Jakob Disease! If the patient is suspected of having Creutzfeldt-Jakob Disease (CJD) or a variant of the Creutzfeldt-Jakob Disease (vCJD) or the latter have been diagnosed, ade­ quate measures must be taken to prevent possible transmission to other patients, users and third parties. Z Disconnect the HF monopolar connection cable from the HF electrode and HF surgical device.

9.1

Reprocessing procedure

.

The following table describes the reprocessing procedure used by Richard Wolf GmbH for validation.

IMPORTANT! ' If used as intended and following the manufacturer's instruction manual, it is

not necessary to limit the number of possible reprocessing cycles. ' Careful and gentle handling of medical products during the entire reprocessing process has an essential influence on the service life of the products. ' Before returning defective products for repair, they must have been subjected to the entire reprocessing cycle. ' The user must ensure that the reprocessing process including the resources, materials and personnel are suitable to achieve the required results. ' The national and international requirements regarding the validation of the user's reprocessing process must be followed.

7

.

IMPORTANT! Further notes and instructions on reprocessing are described in manual GA-J020 "Reprocessing of RICHARD WOLF Heat-Stable Instruments", and these must be followed.

.

IMPORTANT! Do not sterilize the products in hot-air sterilizers.

GA-S010

Product:

HF electrodes

Reprocessing sequence Preparation at the point of use:

Immediately after use, remove coarse soiling from the products. Do not use any cleaning products (e.g. aldehydes) or hot water (>40C) for pre-cleaning as this may bake possible residues to the surfaces.

Transport:

To avoid damage to the products and contamination of the environment, the products must be stored safely in a closed container.

Pre-cleaning:

Dissolve inclustations with 3% hydrogen peroxide solution (H2O2 solution), brush and then rinse with tap water.

Manual Cleaning:

1.Immerse for at least 5 minutes in a certified cleaning solution. 2.Brush with a suitable cleaning brush (86.90) until all visible residues are removed.

(86.90) 3.Immerse the products in a certified cleaning solution. ' Exposure time: 5 min ' Frequency: 35 kHz ' Temperature max.: 45°C 4.At the end, rinse the products with a cleaning gun (3 bar) Disinfection:

1.Immerse the products in an approved disinfectant solution, allow to soak as specified by the manufacturer. 2.At the end, thoroughly rinse the products with water**) for at least 20 seconds.

Drying:

Dry the outer surfaces of the products with a lint-free disposable cloth or swab, or, alternatively, a drying cabinet. Dry hollow spaces with filtered compressed air.

Machine Cleaning:

1.Manually preclean the products before machine cleaning. 2.Fasten the products on the carrier rack of the AWD. Programs without disinfection step alkaline ' >4 min of precleaning with cold water ' empty ' >6 min of cleaning with a cleaning agent at approx. 55C ' empty ' >3 min of neutralization*) (<40C) ' empty ' >2 min of intermediate rinsing (<40C) ' empty

Disinfection:

Carry out thermal machine disinfection following the national requirements with regard to the A0 value (see DIN EN ISO 15883).

Drying:

Dry the products with the drying cycle of the washer-disinfector. If necessary, additional drying can be achieved manually using a lint-free disposable cloth or swab, or, alternatively, a drying cabinet. Dry hollow spaces with filtered compressed air.

Function test, visual check, maintenance:

Check visually for cleanliness. If necessary, repeat the reprocessing procedure until the product is visually clean. Carry out a visual check: see section 8.1

Packaging:

Package the products for sterilization as required by the valid standards.

Sterilization:

Sterilize the products using the fractionated pre-vacuum method (ISO17665) taking into account the national require­ ments. ' Temperature exposure time: 4 min at 134C +4°C (273F +7°F) 132C +4°C (270F +7°F) ' Evacuation: 3x ' Drying time:***) 10 - 20 min ' Maximum sterilization temperature: 138C

Storage:

Store the sterilized products in a dry, clean and dust-free environment at temperatures between 5C and 40C.

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8

Product:

HF electrodes

Reprocessing sequence Validation:

To validate reprocessing, the following materials and machines were used: Manual ' Cleaning agent: Cleaner 0.5% Cidezyme/Enzol (Johnson&Johnson) ' In the case of automatic pre-cleaning: Cleaning agent: Cleaner 0.5% neodisher MediClean (Dr. Weigert)

Additional instructions:

Miele G7735CD Vario-TD Cleaner 0.5% neodisher MediClean (Dr. Weigert)

Sterilization ' Sterilizer:

Selectomat HP 666-1 HRED (MMM)

In accordance with DIN EN ISO 17664 the user is obliged to validate the procedure used. *) **) ***)

9

Machine ' AWD: ' Program: ' Cleaning agent:

Depending on the water quality, add a neutralization solution based on citric acid. If manual disinfection is not followed by sterilization, use sterile water. The drying time depends on the sterilization process used.

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Designation

ENT

Product no.

Thoracoscopy

Illustration

GYNECOLOGY

Item

SURGERY

Technical data and order data

UROLOGY

10

A

823.04

COAG ELECTRODE MONO 4FR WL 400MM

j J j j j

A

823.05

COAG ELECTRODE MONO 5FR WL 400MM

J J J j j

A

823.06

COAG ELECTRODE MONO 6FR WL 400MM

J J J j j

A

823.10

COAG ELECTRODE MONO 10FR WL 400MM

j J j j j

A

823.031

COAG ELECTRODE MONO 3FR WL 580MM

j J j j j

G

823.221

HOOK ELECTRODE MONO 2.4FR WL 600MM

j J j j j

G

824.03

NEEDLE ELECTRODE MONO 2.4FR WL 260MM

j J j j j

G

824.05

NEEDLE ELECTRODE MONO 5FR WL 420MM

J J J j j

G

824.051

HOOK ELECTRODE MONO 5FR WL 620MM

j J j j j

A

8254.02

BUTTON ELECTRODE MONO Ø 2.5MM WL 340MM

j j j J j

A

8383.40

BUTTON ELECTRODE MONO Ø 5MM WL 330MM

J J J j J

A

8384.40

COAG ELECTRODE MONO Ø 5MM WL 450MM

J J J j J

A

8599.80

COAG ELECTRODE MONO 5FR WL 600MM

j J j j j

A

8741.80

COAG ELECTRODE MONO 3FR WL 920MM

j J j j j

A

7223.911

FLEX. BUTTON ELECT MONO Ø 1.1MM WL 600MM

j j j J j

B

8242.301

HOOK ELECTRODE MONO Ø 5MM WL 340MM

j j j j J

B

8379.452

HOOK ELECTRODE MONO Ø 3.5MM WL 310MM

J J J j j

A

8379.462

COAG ELECTRODE MONO Ø 3.5MM WL 310MM

J J J j j

G

8379.482

NEEDLE ELECTRODE MONO Ø 3.5MM WL 310MM

J J J j j

B

8383.423

HOOK ELECTRODE MONO Ø 5MM WL 340MM

J J J j J

G

8383.426

NEEDLE ELECTRODE MONO Ø 5MM WL 340MM

J J J j J

E

8383.428

BLADE ELECTRODE MONO Ø 5MM WL 340MM

J J J j J

F

8383429

MYOMA DISSECTOR MONO Ø 5MM WL 340MM

J J J j j

B

8384.423

HOOK ELECTRODE MONO Ø 5MM WL 420MM

J J J j J

B

8785.642

HOOK ELECTRODE MONO Ø 3.5MM WL 240MM

J J J j j

B

84420.0003 HOOK ELECTRODE MONO Ø 3MM WL 470MM

j j j j J

B

84420.0004 HOOK ELECTRODE MONO Ø 4.9MM WL 330MM

j j j j J

D

84420.0005 MUSHROOM ELECTRODE MONO Ø 7MM WL 335MM

j j j j J

B

84420.0006 HOOK ELECTRODE MONO Ø 4.9MM WL 330MM

j j j j J

J = yes

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j = no

10

10.1

Accessories Item

Illustration

Product no. Designation, Technical data

-

815.xxx

HF CONNECTION CABLE MONO

-

8106.xxx

HF CONNECTION CABLE MONO

-

86.90

CLEANING BRUSH

The products can be combined as required provided the relevant technical data and intended uses are ob­ served. For a general overview please refer to the latest catalog pages, brochures or contact Richard Wolf or your representative.

11

Operating, storage, transport and shipping conditions Operating conditions

+10ºC to +40ºC, 30% to 75% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

Storage, transport and shipping conditions

-20ºC to +60ºC, 10% to 90% rel. humidity, atmospheric pressure 700 hPa to 1060 hPa

.

11.1

NOTE! To prevent damage during transport or shipment of the products we recommend using the original packaging material.

Disposal of product, packaging material and accessories For the disposal observe the relevant regulations and laws valid in your country. ' For further information please contact the manufacturer.

11

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